Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs

Lower Limb Amputation Above Knee (Injury) Clinical Trial

— ASCOPALL  

Official title:

Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05803317
• Other study ID #: Local/2023/EP-01
• Status: Completed
• Start date: August 1, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective, non-randomized, observational, single-center longitudinal study at the University Rehabilitation Hospital of Grau du Roi CHU of Nîmes, France. From January 2012 to Janvier 2023 patients hospitalized for lower limb amputation, were extracted from the computer database of the motion analysis laboratory (2 baropodometric platforms, Zebris, Germany). All patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, were included regardless of the level (trans-femoral or trans-tibial). Only patients hospitalized in the locomotor rehabilitation department were included in the study. Patients who were not autonomous for walking and required a third person (human assistance) were not included. Finally, deceased patients were also excluded from the study population. Prior to data collection, all participants received a note of non-objection. The study was reported on the Health Data Hub, and data collection and analysis were performed according to the MR004 reference methodologies.

Walking amputee patients hospitalized in the locomotor rehabilitation department benefited from a systematic gait assessment before discharge from hospital after rehabilitation and validation of the prosthesis. During the gait analysis, on baropodometric platforms, the software provides a number of parameters: spatiotemporal, pressure distribution, vertical component of the ground reaction force and trajectory of the center of pressure. All patients were recorded over a distance of ten meters including the two meters of acceleration and deceleration according to the validity of the TM-10 for a duration of two minutes.

The parameters from the CoP trajectory are calculated from the coordinates calculated in the platform reference frame. A processing of these data will be specially developed within the service. Three key parameters of the COP have been retained: Lateral symmetry (LS; the left/right offset of the intersection point, where the "zero position" is equivalent to perfect symmetry), lateral variability (LV; the standard deviation of the intersection point in the lateral direction, where "zero" equals constant steps in terms of width between the legs), and anteroposterior variability (APV; the standard deviation of the intersection point in the anteroposterior direction, where "zero" equals constant strides while walking on the treadmill). These parameters, which allow for the assessment of continuous COP trajectories with multiple strides, reflect the overall movements of individuals throughout the gait cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• unilateral or bilateral lower limb amputees, walking with or without technical aids, hospitalized in the Locomotor Rehabilitation Department

• Adult patient (=18 years) and less than 90 years of age.

Exclusion Criteria:

• Patients not autonomous for walking requiring a third person (human assistance) were not included. Finally, deceased patients were also excluded from the study population.

• Patients who objected to the use of their data.

Related Conditions & MeSH terms

• Lower Limb Amputation Above Knee (Injury)
• Lower Limb Amputation Below Knee (Injury)
• Wounds and Injuries

Intervention

Other:
• usual care : Evaluation of walking on a baropodometric platform
Pure observationnal study

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lateral symmetry	Measurement of the lateral symmetry of the center of pressure (LS; the left/right offset of the point of intersection, where the "zero position" is equivalent to perfect symmetry)	Baseline
Primary	Lateral variability	Measurement of the Lateral variability of the center of pressure (LV; the standard deviation of the point of intersection in the lateral direction, where "zero" is equivalent to constant steps in terms of width between the legs)	baseline
Primary	Anteroposterior variability	Measurement of the Anteroposterior variability of the center of pressure (APV; the standard deviation of the point of intersection in the anteroposterior direction, where "zero" is equivalent to constant strides while walking on the treadmill)	baseline
Secondary	Walking speed	Measurement of the median speed according to the level of amputation and the use or not of a technical aid (in m/sec)	baseline